New FDA Warnings about Dangers of Popular Treatments for Low Testosterone

By Cory Watson Attorneys | May 27th, 2015

Almost a year after the FDA announced its investigation into testosterone products, the FDA is issuing new warnings about the dangers of Low-T treatments, including AndroGel, manufactured by AbbVie. The FDA advises against prescribing testosterone treatment to men who experience Low-T symptoms due to aging since the drugs have not been approved for this purpose. The FDA is also requiring all manufacturers of approved prescription testosterone products to clarify the approved uses and add additional warnings about the increased risk of heart attack, stroke, and death.

Low-T is a commonly abbreviated name for low testosterone levels in men. This condition can occur due to disorders of the testicles, pituary gland, or hypogonadism. Testosterone is an FDA-approved replacement therapy for men who have Low-T due to these disorders. However, doctors have been prescribing testosterone treatments, like AndroGel and Axiron, to not only those suffering from these disorders but also men experiencing symptoms for no apparent reason other than aging. The FDA has not approved Low-t treatments for men who experience Low-T symptoms due to aging.1

In January of 2014, the FDA announced that it would evaluate the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products based on the recent publication of two separate studies that each suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy.2These new warning and label changes are a result of this investigation, and the changes are an attempt to curb the overprescribing of Low-T drugs to patients not experiencing hypogonadism or disorders of the testicles and pituary gland. Among the products at issue are AndroGel from AbbVie Inc. and Axiron from Eli Lilly & Co.

In the U.S., the prescription testosterone market exceeded $2 billion in 2013, according to IMS health, an information and technology services provider for the health-care industry. AndroGel from AbbVie was one of the top 100 prescribed medicines in 2013, ranking number 35 in overall sales.3 Low-T treatment products come in the form of gels, transdermal patches, injections and material applied to the gum or cheek.4

This is not the first time the FDA turned its attention to Low-t treatments. The FDA issued another safety communication in June 2014 that required manufacturers of Low-T products to include a warning in the drug labeling about the risk of blood clots in the vein, also known as venous thromboembolism that includes deep vein thrombosis and pulmonary embolism.5

Never stop taking any medication without consulting your doctor.

AndroGel® are registered trademarks of AbbieVie Inc., and are used herein only to identify the products in question. The law fim is not associated with, sponsored by, or affiliated with AbbieVie Inc.

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